Cleared Traditional

K971641 - ANTIBACTERIAL GUTTA PERCHA

K971641 is an FDA 510(k) clearance for ANTIBACTERIAL GUTTA PERCHA, manufactured by Dr. Howard Martin, P.A.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K971641 · Dr. Howard Martin, P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
80d
Days
Class 1
Risk

K971641 is an FDA 510(k) clearance for the ANTIBACTERIAL GUTTA PERCHA. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Dr. Howard Martin, P.A. (Frederick, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K971641

510(k) Number K971641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date July 21, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKM Gutta-percha

All 13
Devices cleared under the same product code (EKM) and FDA review panel - the closest regulatory comparables to K971641.
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
K051573 · Dr. Howard Martin, P.A. · Jun 2006
ENDO TWINN
K042870 · Endo Twinn B.V. · Jan 2005
FIBERFILL SGP
K023819 · Pentron Clinical Technologies · Mar 2003
THERMAPREP PLUS OVEN
K970134 · Tulsa Dental Products, Ltd. · Mar 1997
INJECT-R FILL
K931742 · Union Broach, Div. Moyco Industries, Inc. · May 1993
MICRODOSE RC-EZ
K924825 · Unicep · Mar 1993
K971641 · ANTIBACTERIAL GUTTA PERCHA
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